Heart valve sewing cuff

ABSTRACT

An embodiment of the invention includes a sewing cuff for aortic heart valves that better approximates native anatomy by better mating with the crown-like anatomical annulus. Limiting distortion of the crown-like annulus provides better blood flow and overall valve function and provides a physician greater ease of implantation since native anatomy is not flattened. Thus, the surgeon may attach sutures to the fibrous tissue of the crown-like anatomical annulus without distorting the shape of the native anatomy. An embodiment includes a scalloped sewing cuff assembly (with semilunar arches) that tracks the crown-like annulus. Another embodiment provides a sewing cuff positioned over the majority of the valve&#39;s length, thus allowing the surgeon greater flexibility as to where he or she can attach sutures to the surgical annulus. Conventional valves, which are primarily “low-profile” devices, do not offer such ability. Other embodiments are described herein.

This application is a continuation of U.S. patent application Ser. No.15/131,371, filed Apr. 18, 2016, and entitled “Heart Valve Sewing Cuff,”which is a continuation of U.S. patent application Ser. No. 14/118,656,filed Nov. 19, 2013, entitled “Heart Valve Sewing Cuff,” which is nowU.S. Pat. No. 9,314,333, which was the National Stage of InternationalApplication No. PCT/US2012/039378, filed May 24, 2012, entitled “HeartValve Sewing Cuff,” which claims priority to U.S. Provisional PatentApplication No. 61/636,045, filed Apr. 20, 2012, entitled “MorphologicalSewing Cuff Assembly for Heart Valves,” and U.S. Provisional PatentApplication No. 61/490,188, filed May 26, 2011, entitled “MorphologicalSewing Cuff Assembly for Heart Valves.” The content of each of the aboveapplications is hereby incorporated by reference.

BACKGROUND

As seen in FIG. 1 and addressed in Prosthetic Aortic Valve Replacement(Hans-Hinrich Seivers, Journal of Thoracic and Cardiovascular Surgery,2005, Vol. 129: pp. 961-965), the aortic root includes segments of anellipse where valve cusps are attached to the wall of the aorta and aresupported by thickened, dense fibrous tissue. These fibrous thickeningsform an “anatomic annulus” that has a crown-shaped configuration. InFIG. 1 this crown is depicted by the undulating dashed line of element110. The three elliptical portions of the crown confine the sinuses onone side as the most proximal part of the aorta and the intervalvulartrigones on the other side, which at least hemodynamically belong to theleft ventricle. The dense fibrous tissue of the “anatomic annulus” isstrong and provides an anchor for suturing a prosthetic valve within theaortic root.

There is no solid continuous anatomic circular annulus or ring in whichto place the anchoring sutures as a geometric exact counterpart for theperfectly circular sewing rings of conventional prostheses. A “basicannulus” (see dashed line of element 105 of FIG. 1) consists of thenadirs of the elliptical attachments of the cusps (see element 115 as anexample of one such nadir), the septal muscle, the ventricularmembranous septum, and the distal end of the aortomitral curtain,together termed sometimes the ventriculoarterial junction and definingthe smallest cross-sectional area between the left ventricle and theaorta. As such, this “basic annulus” defines the width of the root asmeasured from the sizers and also the seating of the conventionalcircular prostheses because the prostheses are fixed with suturesthrough the nadirs of the annulus.

A conventional implant technique seats the prosthetic valve alongannulus 105. The sewing ring of the valve is then sutured through thenadirs of the annulus. This restricts the surgeon to placing attachmentsutures in roughly a two dimensional plane (i.e., along ring 105 withlittle vertical (i.e., superior/inferior) variance due to the narrowsewing ring 120). FIG. 2 includes a conventional device with a narrowsewing ring 220. The attachment feature of the ring, namely section 231,may be approximately 0.16 inches in height. This is approximately 38% ofthe entire height 232 (e.g., 0.44 inches) of the valve.

This two dimensional attachment methodology results in a general“flattening” of the annulus region. In other words, rings 110 and 105are flattened together in some instances. Doing so may change thehemodynamic flow of blood upon entering/exiting the prosthetic valve.Specifically, when the surgeon seats the valve he or she must sew alongline 105 of FIG. 1 because that is where the valve's sewing cuff lies.However, fibrous tissue is located along dotted line 110. To access thefibrous tissue (suitable for holding sutures) at line 110 the surgeonattaches sutures along dotted line 110 and then pulls the annulusup/down (i.e., lines 105 and 110 together) to get lines 105 and 110 inthe same plane. As a result, the conventional attachment methodology andsewing rings generally “flatten” the annulus region.

BRIEF DESCRIPTION OF THE DRAWINGS

Features and advantages of embodiments of the present invention willbecome apparent from the appended claims, the following detaileddescription of one or more example embodiments, and the correspondingfigures, in which:

FIG. 1 depicts the aortic root.

FIG. 2 depicts a conventional sewing cuff.

FIG. 3 includes an embodiment of the invention having first and secondsewing cuffs.

FIG. 4 includes an embodiment of the invention having a first sewingcuff.

FIG. 5 includes a method of making an embodiment of the invention.

FIG. 6 includes a method of making an embodiment of the invention.

FIG. 7 includes a method of making an embodiment of the invention.

FIG. 8 includes an embodiment of the invention.

DETAILED DESCRIPTION

In the following description, numerous specific details are set forth.However, it is understood that embodiments of the invention may bepracticed without these specific details. Well-known structures andtechniques have not been shown in detail to avoid obscuring anunderstanding of this description. References to “one embodiment”, “anembodiment”, “example embodiment”, “various embodiments” and the likeindicate the embodiment(s) so described may include particular features,structures, or characteristics, but not every embodiment necessarilyincludes the particular features, structures, or characteristics.Further, some embodiments may have some, all, or none of the featuresdescribed for other embodiments. Also, as used herein “first”, “second”,“third” describe a common object and indicate that different instancesof like objects are being referred to. Such adjectives are not intendedto imply the objects so described must be in a given sequence, eithertemporally, spatially, in ranking, or in any other manner. Also, theterms “coupled” and “connected,” along with their derivatives, may beused. In particular embodiments, “connected” may be used to indicatethat two or more elements are in direct physical or electrical contactwith each other and “coupled” may mean that two or more elementsco-operate or interact with each other, but they may or may not be indirect physical or electrical contact. Also, while similar or samenumbers may be used to designate same or similar parts in differentfigures, doing so does not mean all figures including similar or samenumbers constitute a single or same embodiment.

An embodiment of the invention includes a sewing cuff for aortic heartvalves that better approximates native anatomy by better mating with thecrown-like anatomical annulus. Limiting distortion of the crown-likeannulus provides better blood flow and overall valve function andprovides a physician greater ease of implantation since native anatomyis not flattened. Thus, the surgeon may attach sutures to the fibroustissue of the crown-like anatomical annulus without distorting the shapeof the native anatomy. An embodiment includes a scalloped sewing cuffassembly (with semilunar arches) that tracks the crown-like annulus.Another embodiment provides a sewing cuff positioned over the majorityof the valve's length, thus allowing the surgeon greater flexibility asto where he or she can attach sutures to the surgical annulus.Conventional valves, which are primarily “low-profile” devices, do notoffer such ability. Other embodiments are described herein.

FIG. 3 includes an embodiment of the invention having first and secondsewing cuffs. Prosthetic heart valve 300 comprises a tubular valve bodyhaving longitudinal axis 350, an outlet end (top end of device of FIG. 3which is the “downstream” end of the device), an inlet end (bottom endof device of FIG. 3 which is the “upstream” end of the device), an innersurface, and an outer surface. The outer surface comprises first sewingcuff 321 and second sewing cuff 322, both located entirely between theinlet and outlet ends (i.e., up to/equal to but not beyond the ends). Inother embodiments one or more of the cuffs may not be located entirelybetween the inlets and outlet ends. For example, a portion of cuff 322(and/or cuff 321) may extend further up (past any other portion of thedevice and past the outlet end) to trace the entire fibrous arch of theanatomical crown-like annulus.

In FIG. 3 two leaflets are shown (in their open position) within thetubular valve body. The leaflets intermittently and reversibly sealacross the valve body inner surface to allow unidirectional flow (i.e.,substantially unidirectional flow but not necessarily absoluteunidirectional flow) through the tubular valve body from the inlet endto the outlet end. Embodiments are not limited to any single number ofleaflets.

First cuff 321 includes a first height 334, and a first thickness(determined by subtracting the thickness of second cuff 322 fromdimension 333) and a first outermost diameter 337. Second cuff 322includes a second thickness (determined by subtracting dimension 337from dimension 338 and dividing by two) and a second outermost diameter338. Second cuff 322 includes one or more undulations comprising an apex(element 351 is an example of one or more apexes (a peak of anundulation) that may be included in cuff 322) adjacent a nadir (nadir350 is a “trough” of the undulation that is “adjacent” apex 351 as thereare no other nadirs or apexes between the two). Second sewing cuff 322includes a second height, which is a vertical distance extending fromthe apex (highest point of cuff 322) to the nadir (lowest point of cuff322).

Thus, valve 300 includes cuff 322 with semi-lunar arches shaped to allowthe surgeon to deploy attachment sutures three dimensionally (i.e., withmore vertical variance than found with narrow sewing cuff of FIG. 2) forimproved device implantation. For example, the sutures may be placedalong semi-lunar arches of cuff 322, which generally trace theanatomical crown-like annulus 110. Annulus 310 in FIG. 3 (analogous toannulus 110 of FIG. 1) is shown extending just beyond apex 351 but otherembodiments may extend cuff 322 to extend as far as annulus 310. Valve300 allows the surgeon to place sutures along cuff 322 and along annulus310. This contrasts with traditional “two dimensional” sewing cuffs thatrestrict placement to a thin two dimensional plane of attachment (ring105 of FIG. 1), thus, “flattening” the native annulus.

As used herein, “two dimensional” is not to be taken literally. A “twodimensional” ring (FIG. 2 element 220) obviously has three dimensions.However, the “two dimensional” nomenclature is used herein to indicatethe thin dimension (lack of height) of the conventional ring (sewingring and sewing cuff are used interchangeably herein).

In an embodiment first cuff 321 “passes through” second cuff 322. Theouter perimeter of cuff 321 is thereby included within the innerdiameter of cuff 322.

The embodiment of FIG. 3 includes embodiments wherein cuffs 321, 322 areformed from two pieces or one piece of material. For example, cuffs 321,322 may comprise two pieces of fabric. As seen in FIG. 5, via amultistep process an embodiment is created. First, a short length offabric (e.g., Polytetrafluoroethylene (PTFE)) 522 is provided. Second,one end of the fabric is rolled onto itself on the outside to yield atorroid 523. Then the rolled tube is stitched so it will not unravel.Afterwards the rolled tube may be pressed using dies to achieve ascalloped shape 524. The scalloped shape roll may then be slipped overcuff 521 (which may be a straight-walled thin inner sewing cuffinstalled on a valve 525). Cuff 522 may then be stitched to cuff 521.

In an embodiment a “filler”, such as PTFE felt, may be rolled up insidecuff 522 to add bulk to the sewing cuff. In an embodiment, the fillermay be a polyester fabric or Dacron®, which can be heat set to hold theundulating pattern. The filler may be a material such as titanium, shapememory nitonol, ultra high molecular weight polyethylene (UHMW), and thelike. The filler may be rolled inside the outer cuff during fabricationand then deformed into a scalloped shape using a press, heat press, andthe like to deform or shape the former. With memory materials such asnitinol, the scalloped cuff could be pre-deformed into the former,flattened for assembly with inner cuff 321, and then returned to itsdesired undulating shape.

In an embodiment the scalloped cuff 322 is not limited to being formedfrom a rolled tube. For example, cuff 322 could be a piece of PTFEbraided chord with a round or oval (flattened) cross-section. This chordcould be sewn or otherwise adhered (e.g., via adhesive) to cuff 321(e.g., a straight walled inner sewing cuff).

In another embodiment, cuffs 321, 322 may comprise a shared single pieceof fabric or porous material (e.g., ePTFE). As seen in FIG. 6, a singlepiece of fabric 604 may be wound about elements 602, 603 therebydefining the upper and lower ends of inner cuff 321. Elements 602, 603help the cuff maintain its shape and not slide or slip past or overprojection 605 of valve 606. The same fabric 604 may be wound aboutformer 601 (e.g., nitonol former) to create the outer cuff 322. Such anembodiment may be considered as having first and second cuffs that aremonolithic with one another (in contrast to FIG. 5 having stitchedtogether, non-monolithic cuffs).

In one embodiment the first and second cuffs both comprise fibrousmaterials (e.g., materials composed of fibers such as polyester). Bothof cuffs 321, 322 may be composed of the same material but in otherembodiments they may include differing materials. Thus, both cuffs (notjust one cuff) are suitable for stitching and accepting needles andsutures. Thus, while preferably a surgeon may stitch along cuff 322 heor she may also/instead stitch at any point along cuff 321. This allowsfor variations in anatomic features (such as spacing between fibrousbranches of the crown-like annulus, as further explained below).

FIG. 4 includes an embodiment of the invention disclosing a cuff with anextended height or vertical distance as compared to previous rings(e.g., FIG. 2). The extended height allows the surgeon to deployattachment sutures three dimensionally (i.e., with vertical variance)for improved implantation.

FIG. 4 includes an embodiment having first cuff 421. Prosthetic heartvalve 400 comprises a tubular valve body having longitudinal axis 450,an outlet end (top end of device of FIG. 4 which is the “downstream” endof the device), an inlet end (bottom end of device of FIG. 4 which isthe “upstream” end of the device), an inner surface, and an outersurface. The outer surface comprises first sewing cuff 421 locatedentirely between the inlet and outlet ends. In other embodiments thecuff may not be located entirely between the inlet and outlet ends. InFIG. 4 two leaflets are shown (in their open position) within thetubular valve body but other numbers of leaflets are possible in otherembodiments (as are other types of valve closing mechanisms). First cuff421 includes a first height 434, a first thickness 439 and a firstoutermost diameter 438.

The embodiment of FIG. 4 allows great latitude to a user to suture cuff421 along crown-like annulus ring 410, regardless of the variances ofannulus 410 from patient to patient (and even among the leaflets withina single patient). Regarding variance among leaflets, as noted inAnatomy of the Aortic Valvar Complex and Its Implications forTranscatheter Implantation of the Aortic Valve (Piazza et al.,Circulation Cardiovascular Interventions, 2008, Vol. 1, pp. 74-81),variations exist among individuals in the dimensions of the aortic rootand in the same individual marked variations can exist in all aspects ofthe dimensions of the individual leaflets, including the height, width,surface area, and volume of each of the supporting sinuses of Valsalva.Regarding absolute width of each leaflet expressed as a percentage ofthe width of adjacent leaflets, comparisons of the right coronary andleft coronary leaflets, noncoronary and right coronary leaflets, andleft coronary and noncoronary leaflets varied between 76% and 159%, 62%and 162%, and 62% and 150%, respectively. When the height of eachindividual leaflet was expressed as a percentage of its width, the rightcoronary, noncoronary, and left coronary leaflets varied between 39% and82%, 34% and 87%, and 34% and 113%, respectively.

While the embodiment of FIG. 4 is especially equipped to handlevariances in ring 110, such an embodiment is also able to accommodateother suture preferences that may not necessarily track ring 110 due tothe broadness of the cuff. In other words, cuff 421 provides a broadexpanse for the surgeon to stitch wherever he or she desires.

For that matter, the embodiment of FIG. 3 is also accommodating. Forinstance, cuff 321 still contains a portion with height 334 that couldbe used for suturing if the semi-lunar raised surfaces of cuff 322 donot accommodate the desired suture pattern. This height 334 is stillgreater than the maximum height of conventional cuffs, such as height231 in FIG. 2 (e.g., 0.39 inches vs. 0.16 inches). Thus, cuff 321provides a broad expanse for the surgeon to stitch wherever he or shedesires in addition to or instead of cuff 322.

Regarding dimensions, the conventional device of FIG. 2 includesdimensions 231 (e.g., 0.16 inches) and 232 (e.g., 0.44 inches). Incontrast, FIG. 3 includes an embodiment having dimensions 333 (e.g.,0.18 inches), 331 (e.g., 0.16 inches), 336 (e.g., 4X 0.03 inches,meaning the radius of curvature for the left and right bottom and topcorners as seen in FIG. 3 have 0.03 inch radii of curvature), 337 (e.g.,1.18 inches), 338 (e.g., 1.34 inches), 335 (0.022 inches), 334 (e.g.,0.39 inches), 332 (e.g., 0.56 inches). The embodiment of FIG. 4 includesdimensions 439 (e.g., 0.18 inches), 436 (e.g., 4X 0.03 inches), 438(e.g., 1.34 inches), 435 (e.g., 0.039 inches), 434 (e.g., 0.39 inches),and 432 (e.g., 60 inches).

Also, while not shown, embodiments similar to FIG. 3 may include asemilunar raised service that has a greater dimension 331 than that ofFIG. 3 (e.g., greater than 0.16 inches). As shown in FIG. 3, the height334 may be about 0.39 inches and dimension 331 may be about 0.16 inches.Thus, 0.39−0.16=0.23 of cuff height not occupied by the semilunarsurface of cuff 322. In an embodiment with a broader (greater height)raised semilunar surface, the overall cuff may remain at 0.39 in heightbut the semilunar surface height may grow to, for example, 0.30 leaving0.09 of cuff height not occupied by the semilunar surface. This mayresult in a somewhat flatter semilunar surface angle of curvature. Inother embodiments, the cuff height may be increased from 0.39 to alarger value such as, for example, 0.50 or beyond with care to provideclearance for coronary vessels and other anatomical features that cannotbe covered by a prosthetic. Cutouts or voids may be included in a cuffto avoid such an anatomical feature. This may keep the angle ofcurvature in a broader semilunar surface consistent with that shown inFIG. 3, despite the curved surface being broader than 0.16 in height.

Thus, for the embodiment of FIG. 3 apex 351 includes a top and a bottomand a distance between the top and the bottom (331) is less than 0.2inches. Also, height 334 is greater than 0.3 inches and may be 0.4, 0.5,or 0.6 inches. Further, total valve height extends from the inlet end tothe outlet end (332) and height 334 is greater than 60% of the totalvalve height (332). In other embodiments, the percentage may differ andinclude, for example, 50, 55, 65, 70, 75, 80, 85, 90% and the like. Invarying embodiments, the height from the top of an apex to the bottom ofa nadir may less than, equal to, or more than height 334. In oneembodiment, the apex includes a distance (331) between a top and bottomof the apex. That distance (331) is greater than 40% of height 332.However, in other embodiments that percentage may be 30, 35, 45, 50, 55,65, 70, 75, 80, 85, 90% and the like. In an embodiment height 334 isgreater than the height from the bottom of nadir 350 to the top of apex351. In that same embodiment outermost diameter 337 is less thanoutermost diameter 338. In that same embodiment, the thickness of cuff321 is less than the thickness of cuff 322.

While specific dimensions are mentioned herein those are just examples.Other dimensions and sizes are within the scope of inventiveembodiments. Furthermore, valves may come in varying sizes with cuff(s)that increase/decrease in size accordingly. Kits may be providedincluding variably sized valves.

In an embodiment, the semilunar surfaces (a space between two adjacentapexes) are not equally distributed about the cuff. For example, toaccount for cases where a patient's leaflets have varying widths, avalve with three semilunar surfaces may have one of the three surfaces adifferent length (horizontal) than one or both of the other twosemilunar surfaces. Thus, the user may rotate the valve to situate thelongest semilunar surface (e.g., horizontal distance between troughs orendpoints of semilunar arch) adjacent the longest portion of annulus310. However, in other embodiments the semilunar surfaces are equallydistributed about the cuff. Thus, in one embodiment a first horizontaldistance (reaching between an adjacent apex and nadir) is unequal to asecond horizontal distance (reaching between another adjacent apex nadircouple) so that the undulations are unequally distributed about cuff322.

In an embodiment, a valve with varying rings may be provided in a kit.The user may select from the rings once she or he has inspected thepatient's anatomy. The rings may have varying arrangements of semilunarsurfaces as described above. In various embodiments, the sewing cuffsinclude polyester (e.g., Dacron), polytetrafluoroethylene (e.g.,Teflon), and/or other suitable materials.

Some embodiments, such as one similar to FIG. 4, may include a visiblemarker along the cuff (even though no cuff such as cuff 322 exists) toprovide visual guidance for stitching a cuff along the path of annulus110.

Also, embodiments describing an “undulating” cuff have been discussedabove with regard to FIG. 3, cuff 322. However, an undulating cuff doesnot necessarily have to be contiguous. For example, FIG. 8 includesportions 822, 822′, 822″ that collectively provide an undulating cuffdespite the portions failing to directly connect with each other andinstead indirectly coupling to one another via cuff 821. Further,undulations needs not be smooth (similar to a sine wave) and instead mayresemble a triangular wave, square wave, and the like.

Also, the cuffs of embodiments in FIG. 3 and FIG. 4 are depicted asbeing smooth but other embodiments are not so limited and may includebumps, ridges, and the like. Cuff embodiments may include a verticalridges, ridges set at an angle (e.g., 45 degrees), and/or horizontalridges or bands (e.g., 2, 3 or 4 ridges that circumscribe the cuff). Thevalve may be a bioprosthetic including various portions of donor tissue(e.g., porcine tissue) and the like. Also valves are not only aortic butmay be suitable for mitral valves and the like.

In one embodiment a prosthetic heart valve comprises a tubular valvebody having a longitudinal axis, an outlet end, an inlet end, an innersurface, and an outer surface, the outer surface comprising a firstsewing cuff; wherein the first cuff includes a first height, and a firstthickness and a first outermost diameter both taken orthogonal to thelongitudinal axis. The tubular valve body may include a second sewingcuff that includes a second thickness and a second outermost diameter,both orthogonal to the longitudinal axis. The second cuff does notnecessarily circumscribe the entire first cuff but may instead be aprojection from the first sewing cuff. For example, in an embodimentsimilar to FIG. 8 (including 822′ but not 822 or 822″) cuff 822′projects away from first cuff 821 in a direction non-parallel tolongitudinal axis 850. Both cuff 821 and 822′ are configured to receivesutures so that, based on the patient anatomy, the surgeon may stitchthe valve to the patient at cuff 822′ and/or any location on cuff 821.

Various embodiments of the invention are suitable for implantationintra-annularly, intrasupra-annularly, and supra-annularly. For example,the embodiment of FIG. 4 may be implanted intra-annularly,intrasupra-annularly, and supra-annularly.

An embodiment of the invention includes a method including situating amechanical valve, having a sewing cuff, in a patient's aortic root andsuturing the cuff along the surgical annulus (110 of FIG. 1) whilelimiting or avoiding flattening of surgical annulus 110 and also takinginto account anatomical variances of the fibrous portions of the heartand/or other anatomical issues. The cuff may be sutured along thethickened fibrous portions (see lines 110, 310, 410 for variousexamples) of the patient's fibrous crown-shaped annulus.

An embodiment includes a method of manufacturing a cuff. For example,FIG. 7 depicts a two piece mandrel with mating scalloped surfaces 701,702. The two pieces slide coaxially on a center rod passing through theopen leaflets of the valve. The two parts of the mandrel, when broughttogether, squeeze the base of the protruding portions of sewing cuff 722into shape and hold it for stitching and coupling it to cuff 721. Narrowslits 703 in each mandrel half allow a curved needle to pass throughsewing cuffs 721, 722 to secure them together. The stitches may betemporary or permanent. The method of FIG. 7 may work with theembodiment of FIG. 6. However, the method of FIG. 7 may also work withtwo piece embodiments (e.g., sew a separate sewing cuff flange onto avalve for a two piece cuff configuration such as FIG. 5).

While the present invention has been described with respect to a limitednumber of embodiments, those skilled in the art will appreciate numerousmodifications and variations therefrom. It is intended that the appendedclaims cover all such modifications and variations as fall within thetrue spirit and scope of this present invention.

1. A prosthetic heart valve comprising: a tubular valve body having avertical axis, an outlet end, and an inlet end; a sewing cuff locatedentirely between the inlet and outlet ends; and at least one leaflet tointermittently allow flow through the tubular valve body from the inletend to the outlet end; wherein the sewing cuff includes a first portioncomprising: (a)(i) first height that is uniform along an upper edge ofthe first portion, and (a)(ii) a first outermost diameter takenorthogonal to the vertical axis; wherein the sewing cuff includes asecond portion comprising: (b)(i) undulations that each comprise an apexadjacent a nadir, (b)(ii) a second height extending from a top of theapex to a bottom of the nadir, and (b)(iii) a second outermost diametertaken orthogonal to the vertical axis; wherein both of the first andsecond portions include a fabric; wherein the second height is at least75% of the first height; wherein the second outermost diameter isgreater than the first outermost diameter; wherein the tubular valvebody includes a projection that extends horizontally away from thevertical axis; wherein a subportion of the first portion is above theprojection and an additional subportion of the first portion is belowthe projection; and wherein the projection, subportion, and additionalsubportion are oriented in relation to each other such that theprojection resists the subportion and additional subportion from slidingoff the tubular valve body.
 2. The valve of claim 1 wherein the firstportion includes a cylindrical portion.
 3. The valve of claim 2 whereinthe cylindrical portion includes a circular perimeter that defines thefirst outermost diameter.
 4. The valve of claim 1 wherein the first andsecond portions share a single, monolithic portion of the fabric.
 5. Thevalve of claim 1 wherein the apex is directly connected to the nadir. 6.The valve of claim 1 wherein the first and second portions are bothconfigured to accept and retain sutures.
 7. The valve of claim 1 whereinthe first and second portions are non-monolithic with one another. 8.The valve of claim 1 wherein: the second portion does not extend abovethe first portion; the second portion does not extend below the firstportion.
 9. The valve of claim 1 wherein: the first and second portionsshare a single, monolithic portion of the fabric; a radial axis,radiating horizontally outward from and orthogonal to the vertical axis,intercepts the monolithic portion of the fabric at least 3 times; andthe horizontal axis intercepts the projection.
 10. The valve of claim 9wherein an additional vertical axis intercepts the monolithic portion ofthe fabric at least 3 times.
 11. The valve of claim 1 wherein theprosthetic heart valve is not a bioprosthetic.
 12. The valve of claim 1wherein the fabric includes a member selected from the group comprisingpolyester, polyethylene terephthalate, and polytetrafluoroethylene(PTFE).
 13. A prosthetic heart valve comprising: a tubular valve bodyhaving a vertical axis, an outlet end, and an inlet end; a sewing cufflocated entirely between the inlet and outlet ends; and at least oneleaflet to intermittently allow flow through the tubular valve body fromthe inlet end to the outlet end; wherein the sewing cuff includes afirst portion comprising: (a)(i) first height that is uniform along anupper edge of the first portion, and (a)(ii) a first outermost diametertaken orthogonal to the vertical axis; wherein the sewing cuff includesa second portion comprising: (b)(i) undulations that each comprise anapex adjacent a nadir, (b)(ii) a second height extending from a top ofthe apex to a bottom of the nadir, and (b)(iii) a second outermostdiameter taken orthogonal to the vertical axis; wherein both of thefirst and second portions include a fabric; wherein the second outermostdiameter is greater than the first outermost diameter; wherein thetubular valve body includes a projection that extends horizontally awayfrom the vertical axis; wherein a subportion of the first portion isabove the projection and an additional subportion of the first portionis below the projection; and wherein the projection, subportion, andadditional subportion are oriented in relation to each other such thatthe projection resists the subportion and additional subportion fromsliding off the tubular valve body.
 14. The valve of claim 13, wherein:the first portion includes a cylindrical portion; the cylindricalportion includes a circular perimeter that defines the first outermostdiameter. the first and second portions are both configured to acceptand retain sutures; the projection extends orthogonal to the verticalaxis; the second portion does not extend above the first portion; andthe second portion does not extend below the first portion.
 15. Thevalve of claim 13 wherein the fabric includes a member selected from thegroup comprising polyester, polyethylene terephthalate, andpolytetrafluoroethylene (PTFE).
 16. The valve of claim 13 wherein thesecond height is at least 75% of the first height.
 17. A prostheticheart valve comprising: a tubular valve body having a vertical axis, anoutlet end, and an inlet end; a sewing cuff located entirely between theinlet and outlet ends; and at least one leaflet to intermittently allowflow through the tubular valve body from the inlet end to the outletend; wherein the sewing cuff includes a first portion comprising: (a)(i)first height that is uniform along an upper edge of the first portion,and (a)(ii) a first outermost diameter taken orthogonal to the verticalaxis; wherein the sewing cuff includes a second portion comprising:(b)(i) undulations that each comprise an apex adjacent a nadir, (b)(ii)a second height extending from a top of the apex to a bottom of thenadir, and (b)(iii) a second outermost diameter taken orthogonal to thevertical axis; wherein both of the first and second portions include afabric; wherein the second outermost diameter is greater than the firstoutermost diameter; wherein the tubular valve body includes a projectionthat extends horizontally; wherein a subportion of the first portion isabove the projection and an additional subportion of the first portionis below the projection; and wherein the projection, subportion, andadditional subportion are oriented in relation to each other such thatthe projection resists the subportion and additional subportion fromsliding off the tubular valve body.
 18. The valve of claim 17 whereinthe fabric includes a member selected from the group comprisingpolyester, polyethylene terephthalate, and polytetrafluoroethylene(PTFE).
 19. The valve of claim 17 wherein the second height is at least75% of the first height.
 20. The valve of claim 17 wherein theprojection extends orthogonal to the vertical axis.